Last reviewed · How we verify
Standard dose valproate
Standard dose valproate, marketed by the Mario Negri Institute for Pharmacological Research, holds a significant position in its therapeutic segment. The key composition patent, set to expire in 2028, provides a strong barrier to generic competition in the near term. The primary risk lies in the potential for increased competition once the patent expires, which could erode market share and revenue.
At a glance
| Generic name | Standard dose valproate |
|---|---|
| Also known as | Standard valproate |
| Sponsor | Mario Negri Institute for Pharmacological Research |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer (PHASE2)
- Valproate for the Treatment of Residual Amblyopia (PHASE1, PHASE2)
- Valproic AcId for Traumatic BRAin INjury Trial (PHASE2, PHASE3)
- Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal Cancer (PHASE2)
- Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients (PHASE2)
- Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) (PHASE4)
- Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation-2 (TELSTAR-2) (NA)
- Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Standard dose valproate CI brief — competitive landscape report
- Standard dose valproate updates RSS · CI watch RSS
- Mario Negri Institute for Pharmacological Research portfolio CI